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Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Biogen Inc. (BIIB)  More Company Research Source: GlobeNewswire
Last biogen inc. earnings: 4/22 07:12 am Check Earnings Report
US:NASDAQ Investor Relations: biogen.com/en_us/investors.html
Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1Biogen is dedicated to partnering with the SMA community to advance care through scientific innovation and a commitment to enhancing outcomes for people living with SMA CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases.2 The SPINRAZA European Union marketing authorization has been updated to include the high dose regimen. The new high dose regimen comprises a more rapid loading phase, two 50 mg loading doses administered 14 days apart [Read more]
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Stockreport

Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Biogen Inc.  (BIIB) 
More Company Research Source: GlobeNewswire
Last biogen inc. earnings: 4/22 07:12 am Check Earnings Report
US:NASDAQ Investor Relations: biogen.com/en_us/investors.html
Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1Biogen is dedicated to partnering with the SMA community to advance care through scientific innovation and a commitment to enhancing outcomes for people living with SMA CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases.2 The SPINRAZA European Union marketing authorization has been updated to include the high dose regimen. The new high dose regimen comprises a more rapid loading phase, two 50 mg loading doses administered 14 days apart [Read more]
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